Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
dopamine hydrochloride, Quantity: 40 mg/mL
Pfizer Australia Pty Ltd
Injection, concentrated
Excipient Ingredients: sodium metabisulfite; water for injections
Intravenous
5 x 5 mL
(S4) Prescription Only Medicine
INDICATIONS AS AT 31 October 2003: For the correction of haemodynamic imbalance present in: Acute hypotension or shock associated with myocardial infarction, endotoxic septicaemia, trauma and renal failure. As an adjunct after open heart surgery, where there is persistent hypotension after correction of hypovolaemia. In chronic cardiac decompensation as in congestive failure.
Visual Identification: Clear colourless or pale yellow solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1991-10-08
DBL™ STERILE DOPAMINE CONCENTRATE _Dopamine (DO-pa-meen)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL Sterile Dopamine Concentrate. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given DBL Sterile Dopamine Concentrate against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE. YOU MAY NEED TO READ IT AGAIN. WHAT DBL STERILE DOPAMINE CONCENTRATE IS USED FOR Dopamine acts in different ways, depending on the dose given. At low doses, dopamine increases blood flow to the kidneys. At higher doses, it increases the blood flow to the muscles and can increase the heart’s pumping efficiency. Dopamine may be used to increase low blood pressure in people who have: • experienced a heart attack • a severe infection • lost blood during an accident • kidney failure • problems after surgery. Dopamine may be used to help the heart pump better in some people with congestive heart failure. Your doctor may have prescribed DBL Sterile Dopamine Concentrate for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DBL STERILE DOPAMINE CONCENTRATE HAS BEEN PRESCRIBED FOR YOU. There is no evidence that dopamine is addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN DBL STERILE DOPAMINE CONCENTRATE _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU MUST NOT BE GIVEN DBL STERILE DOPAMINE CONCENTRATE IF YOU HAVE AN ALLERGY TO DOPAMINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. YOU SHOULD NOT BE GIVEN DOPAMINE IF YOU HAVE ANY Baca dokumen lengkap
Version: pfpdopai10821 Supersedes: pfpdopai10619 Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION – DBL™ STERILE DOPAMINE CONCENTRATE (DOPAMINE HYDROCHLORIDE) 1. NAME OF THE MEDICINE Dopamine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dopamine hydrochloride is a naturally occurring biochemical catecholamine precursor of noradrenaline and adrenaline. The chemical name of dopamine hydrochloride is 4-(2- aminoethyl) benzene-1,2-diol hydrochloride and has the chemical formula C 8 H 11 NO 2 .HCl. DBL Sterile Dopamine Concentrate is a sterile solution of Dopamine Hydrochloride BP in water for injection, containing 1% sodium metabisulfite. The strength supplied is 200 milligrams/5 mL in a clear glass ampoule. EXCIPIENT WITH KNOWN EFFECT Sodium metabisulfite For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3. PHARMACEUTICAL FORM Dopamine hydrochloride is a white, odourless powder, freely soluble in water and soluble in alcohol. It is sensitive to light, alkalis, iron salts and oxidising agents. The pH of the solution is approximately 4. IT MUST BE DILUTED BEFORE USE. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the correction of haemodynamic imbalance present in: Acute hypotension or shock associated with myocardial infarction, endotoxic septicaemia, trauma and renal failure. As an adjunct after open heart surgery, where there is persistent hypotension after correction of hypovolaemia. In chronic cardiac decompensation as in congestive failure. 4.2 DOSE AND METHOD OF ADMINISTRATION WARNING: DOPAMINE IS A POTENT DRUG. IT MUST BE DILUTED BEFORE ADMINISTRATION. DO NOT ADD TO ALKALINE SOLUTIONS SUCH AS SODIUM BICARBONATE, AS THESE INACTIVATE DOPAMINE . Version: pfpdopai10821 Supersedes: pfpdopai10619 Page 2 of 14 In appropriate cases, restoration of blood volume with plasma, whole blood, or a suitable plasma expander, should be instituted prior to administration: central venous pressure should be 10 to 15cm H 2 O, or pulmonary wedge pressure 14 to 18mm Hg. DOSAGE _ADULT _ When ap Baca dokumen lengkap